Mission-critical decisions are delayed, trapping new international revenue until market clearance process issues are resolved. Workflow is confounded as information conflicts from sales-focused distributors, newly-appointed foreign regulators, and legacy resources are reconciled- and as definitive answers are sought. Governance is compromised as information gaps reduce assurance levels and impair risk management of clearance-related penalties, fines, and legal costs.

And the high level of business performance required to create value from ongoing medtech industry consolidation is not achievable, since global market clearance operations are incapable of rapidly completing new market clearance submissions for newly-acquired product lines.

This is because clinivation WorldView is designed, optimized, and proven to accelerate the processes and workflow specific to the global market clearance operations for medical devices, diagnostics, hospital supplies, and dental supplies.

Supporting Resources:

For more information on the clinivation Enterprise Solution for On-Demand Global Regulatory Intelligence and Client-Directed Case Research Solutions, please visit the clinivation WorldView homepage.

For more information on the clinivation Enterprise Solution for Global Market Clearance Management, please visit the clinivation Global homepage.

About OptiMedica:

OptiMedica Corporation is a Silicon Valley-based global ophthalmic device company dedicated to developing performance-driven technologies that improve patient outcomes. The company was founded in 2004 with the vision of bringing innovative new technologies to ophthalmologists and transforming existing standards of care.

Since its founding, OptiMedica has been developing a reproducible, noninvasive technique to replace the inconsistent manual steps in cataract surgery with femtosecond laser technology. The system has been designed to deliver new levels of precision, control, performance, and efficacy to cataract surgeons and their patients. OptiMedica has completed clinical trials of its Catalys™ Precision Laser System, with very promising results reported across these measures.

OptiMedica has a legacy of delivering transformational change in ophthalmology. The company’s initial commercial effort was in retina, where its research and development team sought to rethink panretinal photocoagulation (PRP) to dramatically improve the precision, efficiency and comfort of the procedure. OptiMedica licensed pattern scanning laser technology from Stanford University, and its PASCAL® (PAttern SCAn Laser) Method of photocoagulation transformed the retinal photocoagulation market.

About clinivation

Clinivation solutions deliver the digital advantage to outperform in new business environments with innovative and better ways to succeed in global development and commercialization.

Our cross‐functional software brings people and knowledge to the point of action to eliminate revenue traps, overcome process complexity, and enable execution with full visibility, decision support, and controls.

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Customers

Clinivation solutions deliver the digital advantage to outperform in new business environments with innovative and better ways to succeed in global development and commercialization.

Our cross‐functional software brings people and knowledge to the point of action to eliminate revenue traps, overcome process complexity, and enable execution with full visibility, decision support, and controls.